Australia flagARTG 390330

Ambulatory insulin infusion pump software, patient-dosing

ARTG ID: 390330 · Ypsomed Australia Pty Ltd · CamDiab Ltd · Class IIb · Started June 14, 2022

Good Name: Ypsomed Australia Pty Ltd - Ambulatory insulin infusion pump software, patient-dosing

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
390330
Start Date
June 14, 2022
Effective Date
June 14, 2022
Sponsor
Manufacturer
Country
United Kingdom
Address
Level 4 Institute of Metabolic Science Box 289 Addenbrooke's Hospital Hills Road, Cambridge, CB2 0QQ
Intended purpose

The App is used to manage glucose levels in people with type I diabetes, aged 1 year and older, using a hybrid closed-loop approach. Additional age restrictions may apply depending on the chosen continuous glucose monitor and insulin pump.

About this record

Access comprehensive regulatory information for Ambulatory insulin infusion pump software, patient-dosing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 390330 and sponsored by Ypsomed Australia Pty Ltd, manufactured by CamDiab Ltd in United Kingdom. The device registration started on June 14, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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